Psilocybin + Psychotherapy for Demoralization
(PATH Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByYvan Beaussant, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yvan Beaussant

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This trial tests a treatment using psilocybin, a substance from certain mushrooms, combined with talk therapy for hospice patients feeling demoralized. The goal is to see if this approach can safely reduce their emotional distress. Psilocybin recently received breakthrough status by the FDA for its use in treatment of depression.

Eligibility Criteria

This trial is for adults over 21 in hospice care with any terminal illness, experiencing moderate-to-severe demoralization. They must have a caregiver present after taking the study drug and not drive for 24 hours post-administration. Participants need to use contraception if of childbearing potential. Exclusions include those with certain psychiatric conditions or family history, significant suicide risk, allergies to similar drugs, or on medications that could interact poorly.

Inclusion Criteria

English proficiency

Moderate-to-severe demoralization as measured by Demoralization Scale-II ≥ 8

You have a very serious illness that cannot be cured.

+9 more

Exclusion Criteria

You have a history of mental health conditions like schizophrenia, bipolar disorder, or personality disorders.

I have trouble eating or absorbing food.

My primary reason for hospice care is end-stage liver disease or cirrhosis.

+11 more

Participant Groups

The study tests psilocybin-assisted psychotherapy's effectiveness in reducing feelings of hopelessness among terminally ill patients receiving hospice care. Psilocybin is administered under controlled conditions alongside sessions of psychotherapy to evaluate its impact on demoralization.

1Treatment groups

Experimental Treatment

Group I: PATHExperimental Treatment2 Interventions

The research study procedures include screening for eligibility, and study intervention including preparation, evaluations, one psilocybin session and follow up visits. -The treatment regimen consists of a single administration of psilocybin 25 mg orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions

Psilocybin is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Psilocybin for: